New hope for liver cancer: drug combo trial launches
NCT ID NCT05441475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a new drug, ABSK-011, combined with the immunotherapy atezolizumab (or standard care) in 118 people with advanced or unresectable hepatocellular carcinoma, a type of liver cancer. The study aims to see if the combination is safe and can shrink tumors. Participants must have a specific genetic marker (FGF19 overexpression) and have not had prior systemic therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABSK-011 (a targeted cancer drug) combined with atezolizumab (an immunotherapy) or standard care
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced liver cancer that has not responded to other therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply to everyone. Side effects from the drug combination could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 118 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. Subjects should be able and willing to follow the study follow-up and study procedures in the protocol. 2. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old. 3. part a: subjects with advanced or unresectable HCC who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child Pugh score is 5-6. Part b: subjects with advanced or unresectable HCC who must be confirmed histologically or cytologically, are not suitable for curative surgery and / or local regional treatment, and have not previously received systematic treatment or only received first-line systematic treatment- Part C: Subjects with histologically or cytologically confirmed advanced or unresectable HCC who are not eligible for curative surgery and/or locoregional therapy and have not received prior systemic therapy, and who meet the following criteria: 1. Provide archived tumor tissue samples or undergo biopsy for FGF19 overexpression testing at the central laboratory. 2. BCLC stage B or C, Child-Pugh score 5-6, no hepatic encephalopathy, and no ascites requiring medical intervention within 7 days prior to the first dose. 3. At least 1 measurable target lesion per RECIST 1.1. For subjects who received prior locoregional therapy (e.g., transarterial (chemo)embolization, radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, etc.), the target lesion must not have been treated with the above locoregional therapies, or the investigator has confirmed disease progression or absence of clinical benefit in the target lesion after prior locoregional therapy. 4. Treatment with up to one cycle of a PD-1/PD-L1 inhibitor, with or without a VEGF inhibitor, prior to enrollment is permitted. Exclusion Criteria: 1. history of autoimmune diseases 2. have a history of the second primary malignant tumor other than HCC within 5 years before screening, 3. have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels. 4. meningeal metastasis or central nervous system (CNS) metastasis -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Hubei, Shanghai Municipality, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial